NCT00820742撤回不适用
The Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Incidence of adverse events and serious adverse events
研究概览
简要总结
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.
详细描述
Open-label, non-comparative, non-interventional study
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have at least one eye which was diagnosed with neovascular degeneration
排除标准
- •Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis
研究组 & 干预措施
Phase IV Post Marketing Surveillance Study
Open-label, observational study
干预措施: Macugen (Drug)
结局指标
主要结局
Incidence of adverse events and serious adverse events
时间窗: 12 months
次要结局
- Mean change in visual acuity in the study eye at 6 months from baseline(6 months)
研究者
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